haralson



24, 1956 R. H- HARALSON, JR

PHARMACEUTICAL DISPENSER Filed Sept. 26, 1952 II 'ILI II' I I I ROBERTH. HARALSOBLJR.

INVEN TOR.

l BY WK QW ATTOR/L/[V United States Patent PHARMACEUTICAL DISPENSERRobert H. Haralson, Jr., Maryville, Tenn. Application September 26,1952, Serial No. 311,749

9 Claims. (Cl. 128-272) This invention relates to a device for marketingand/ or dispensing certain pharmaceutical preparations.

The principal object of the present invention is to provide a solventcontainer with an ampule disposed therein adapted for quick preparationof pharmaceutical materials for emergency or normal treatment ofpatients as required.

Another object of this invention is to provide a device for thepreparation of therapeutic materials in a quantity suitable for a numberof treatments requiring the same a device for the ultimate preparationof pharmaceutical materials for dispensing promptly and in a mosteconomical manner.

The pharmaceutical dispenser of the present invention is essentially thecombination of a solvent or diluent container, a closure for saidsolvent container adapted for the ready withdrawal of prepared solutiontherefrom, a sealed solute container within said solvent container, andmeans for the rupture of the wall of said solute container extendingthrough said solvent container closure. The application of externalforce may then be applied to produce the rupture of the solute containerand result in the immediate dilution: or solution of the solute in thesolvent.

In the accompanying drawing wherein the same reference numeral refers tothe same part in the various views,

Fig. 1 is a substantially vertical sectional view of one embodiment ofthe present invention wherein the rupture of the solute container isproduced by a rapid withdrawal of at least a part of the rupturingelement through the solvent container closure,

Fig. 2 is a substantially vertical sectional view of another form ofthis invention wherein the rupture of the solute container is producedby sharp impact on that portion of the rupturing element extendingoutside the solvent container closure,

Fig. ,3 is a view similar to Fig. 1, except that a substantially rigidsupport for the solute container is provided, and

Fig. 4 is a view similar to Fig. 2, except that a substantially rigidpositioning means for the solute container is provided.

In all of the figures, solvent container 1 holds solvent 3 and solutecontainer 5 with solute 7 therein, and is provided with closure 9.Closure 9.is penetrated by air inlet 11, which extends to the bottom ofsolvent container 1, and is perforated in part to provide outlet 13through 2,731,965 Patented Jan. 24, 1956 which a hypodermic needle orthe inlet of any other type of liquid administration set (not shown) maybe inserted. Closure 9 and inlet 11 are covered by separable diaphragm15, which is in turn protected by covering seal 17.

In Fig. 1 and Fig. 3, a rupture means 19 consists of a wirelike memberwhich engages solute container 5, extends through closure 9, andterminates in loop 21. Diaphragm 15 covers closure 9, inlet 11 and loop21 securely and protects the entire top of the assembly during and aftersterilization of the dispenser combination.

In Fig. 3 restraining means 23 holds solute container 5 in apredetermined position by engagement with closure 9.

In preparing solute 7 for dispensing, seal 17 and diaphragm 15 areremoved. Loop 21 of rupture means 19 is raised and withdrawn rapidly andto the extent that the wall of solute container 5 is ruptured by sharpcontact with either the shoulder of solvent container 1, or therestraining means 23. Solute 7 dissolves immediately in solvent 3 withagitation at least to the extent of producing a uniform concentrationthroughout. A hypodermic needle or the inlet of anadministration set(not shown) is introduced into outlet 13, the entire dispenser combination inverted and supported, and a predetermined amount of solutionwithdrawn from container 1, or the solution is withdrawn at apredetermined rate from container 1 until the required amount ofsolution is dispensed. On again inverting the dispenser combination toits original position and removing the administration set inlet, thediaphragm 15 and seal 17 may be replaced and the remainder of thesolution in container 1 retained for subsequent dispensing of successiveportions of the solution.

In Fig. 2 and Fig. 4, a rupture means 25 consists of a rodlike member,just engaging the solute container 5, extends through closure 9 and ashort distance beyond as terminal 27. Diaphragm 15 and seal 17 coverclosure 9, inlet 11, and terminal 27, thereby protecting these elementsof the combination during and after sterilization.

In preparing solute 7 for dispensing, seal 17 and diaphragm 15 areremoved, a sharp impact applied to terminal 27 to the extent that thewall of solute container 5 is ruptured by contact with the bottom ofcontainer 1. Mixing and dispensing are carried out as described above.

In Fig. 4 the solute container 5 is held in place by restraining element29.

The term solvent as used in the description and claims refers to thatconstituent of the ultimate solution for dispensing which is present inthe larger amount, or which is liquid in the original or pure state.Such solvent may be distilled water, or any base suitable for thepreparation of the material being dispensed, such as solutions ofdextrose, invert sugar, or salt in water.

The term solute refers to that constituent of the ultimate solutionwhich is considered to be dissolved in the other constituent, calledsolvent. The solute is usually either a liquid or solid. Such solute maybe a material required for therapeutic treatment in a diluting medium ofa suitable solvent, or in admixture with other desirable materialsalready in solution. Examples of solutes requiring dissolution beforeinjection include thionembutal, thiopental and thioseconal, which may beused in appropriate concentrations to produce amnesia or anesthesia.Blood plasma concentrate may also be used in preparations forintravenous introduction.

The solvent container may be any suitably shaped bottle or flask with atleast a medium sized neck and mouth for accommodation of a closure forsame together with other elements associated therewith as set forthherein. The bottle or flask serving as solvent container preferablyshould be cylindrical and marked with appropriate volumetricgraduations.

The solute container is of the type normally employed in packaging anddistributing concentrated and/or perishable material through the usualchannels of trade to hospitals and/ or physicians. Such containers, orampoules, usually are sealed, thin-walled glass containers soconstructed as to be readily fractured or ruptured at the end or middlethereof. Of course, any such container constructed from any otherfriable, plastic material is adequate for the purpose of this invention.

The means for rupture of the solute container must be in juxtapositionto the container in such a manner that the application of force from theoutside of the solvent container through such rupture means will resultin breaking the wall of the solute container at least to the extent thatthe solute therein will be fully exposed to solvent surrounding it. Therupture means may be actually attached to the solute container, or maybe so closely associated with such container that the application of theexternal force will cause rupture of the wall of the container.

The rupture means extends from the solute container up through thesolvent container closure to such an extent that force may be appliedthereto externally in respect to the solvent container to cause ruptureof the solute container.

When it is desired to apply such external force by traction, or rapidwithdrawal, the rupture means may be a Wire-like element attached to thesolute container, extending through the solvent container closure, andprovided with a looped end, or other suitable configuration forgrasping, which may fit snugly on the top of said closure. Aftergrasping such loop, a rapid withdrawal of a portion of the Wire throughthe closure will cause the rupture of the thin-walled, solute container,either by the resulting impact against the shoulder below the neck ofthe solvent container, or by impact with other restraining means ashereinafter described in detail.

When it is desired to apply such external force by transmitted impact, arelatively rigid rupture means is provided with one end so shaped andpositioned as to gently engage the solute container. This rigid rodextends through and beyond the solvent container closure, but preferablynot above the top of the neck of the solvent container. A sharp impacton the exposed terminal portion of this rod produces the rupture of thesolute container.

The closure for the solvent container is of such composition, size andconstruction as to accommodate the rupture means, the solute containerrestraining means if used, the air inlet conduit and the solution outletcorresponding to the location of the administration set inlet. Thesolution outlet is preferably a preformed aperture in the closure whichdoes not extend completely through the top of the closure, therebypermitting the introduction of either a hypodermic needle or the tube ofa standard administration set.

A filtering screen or sieve may be associated with said closure in orderto filter the resulting solution being dispensed, if required. However,administration sets usually contain some type of filtering element.

A separable diaphragm on top of the solvent container neck covers thesolvent container closure, the rupture means terminal, the air inlet andthe solution outlet zone. This diaphragm may be a separate member, or apart of a unitary element which serves both as a gas-tight cover and aseal for full protection of the entire dispenser combination duringsterilization, distribution and/ or storage. The configuration of theseal is such as to conform to, and at the same time protect, thatportion of the rupture means above the top of the closure fromaccidental application of external force.

On removing the seal and diaphragm, the solute container can then beruptured by the application of external force and the desired solutionproduced. After introduction of a hyperderrnic needle or administrationset inlet to the solution outlet in the solvent container closure,

the entire dispenser assembly is inverted and the desired amount ofsolution withdrawn. Thereafter, the assembly is returned to its originalposition, the administration inlet withdrawn and the assembly closed bydiaphragm and seal replacement.

The solvent container may be provided with a means for restraining thesolute container in a predetermined position in order to apply moreeffectively the external force for rupturing the wall of the solutecontainer.

Such restraining means may be constructed of wirelike er rcdlikeelements depending on the character of force to be applied, tractive orimpact. The configuration of the restraining element is such as to holdthe solute container in a relatively fixed position and be anchored tothe closure of the solvent container.

Alternately, the configuration of the solvent container may be changedfrom the aforesaid cylindrical type of vessel by suitable indentationsor other change in shape in order to engage the solute container in asuitable position. such as near the top or near the bottom of thesolvent container.

1 claim:

1. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means for shock rupture of the wall of said solutecontainer in juxtaposition to said solute container and extendingthrough said solvent container closure, and a gas-tight sealing elementcovering said solvent container closure and that portion of said rupturemeans extending therethrough.

2. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted for shockrupture of the wall of said solute container by rapid withdrawal of thatportion extending above said closure, and a gas-tight sealing elementcovering said solvent container closure and that portion of said rupturemeans extending therethrough.

3. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container Within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted for shockrupture of the wall of said solute container by sharp impact on thatportion thereof extending above said closure, and a gas-tight sealingelement covering said solvent container closure and that portion of saidrupture means extending therethrough.

4. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted for shockrupture of the wall of said solute container by rapid withdrawal of thatportion extending above said closure, means for restraining said solutecontainer in a predetermined position Within said solvent container, anda gas-tight sealing element covering said solvent container closure andthat portion of said rupture means extending therethrough.

5. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means in juxtaposition to said solute i l l icontainer extending through said solvent container closure and the upperend thereof extending through the top of said closure adapted for shockrupture of the wall of said solute container by sharp impact on thatportion thereof extending above said closure, means for restraining saidsolute container in a predetermined position within said solventcontainer, and a gas-tight sealing element covering said solventcontainer closure and that portion of said rupture means extendingtherethrough.

6. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted for shockrupture of the wall of said solute container by rapid withdrawal of thatportion extending above said closure, means for restraining said solutecontainer in a predetermined position within said solvent container heldin position by engagement with said solvent container closure, and agas-tight sealing element covering said solvent container closure andthat portion of said rupture means extending therethrough. 7. Apharmaceutical dispenser comprising a solvent container, a closure forsaid solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted for shockrupture of the wall of said solute container by sharp impact on thatportion thereof extending above said closure, means for restraining saidsolute conatiner in a predetermined position within said solventcontainer held in position by engagement with said solvent containerclosure, and a gas-tight sealing element covering said solvent containerclosure and that portion of said rupture means extending therethrough.

8. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted to shockrupture of the Wall of said solute container by rapid withdrawal of thatportion extending above said closure, means for restraining said solutecontainer in a predetermined position within said solvent container heldin position by engagement with said solvent container closure, aseparable diaphram covering said solvent container closure and thatportion of said rupture means extending therethrough, and a seal oversaid diaphram.

9. A pharmaceutical dispenser comprising a solvent container, a closurefor said solvent container, an air conduit through said closure to thebottom of said solvent container, a sealed solute container Within saidsolvent container, means in juxtaposition to said solute containerextending through said solvent container closure and the upper endthereof extending through the top of said closure adapted to shockrupture of the Wall of said solute container by sharp impact on thatportion thereof extending above said closure, means for restraining saidsolute container in a predetermined position within said solventcontainer held in position by engagement with said solvent containerclosure, a separable diaphram covering said solvent container closureand that portion of said rupture means extending therethrough, and aseal over said diaphram.

References Cited in the file of this patent UNITED STATES PATENTS2,236,491 Campbell Mar. 25, 1941 2,275,567 Smith Mar. 10, 1942 2,387,978Casey Oct. 30, 1945 2,619,448 Larsen Nov. 25, 1952 FOREIGN PATENTS122,370 Australia Oct. 10, 1946 716,477 France Oct. 6, 1931

